Regulatory Affairs
Our regulatory consultants provide strategic and lifecycle regulatory affairs consulting services for all healthcare sectors including pharmaceutical products and medical devices. We can assist with all European regulatory activities across all phases of development and lifecycle maintenance.
Medicinal Products
We work with prescription pharmaceuticals (new chemical entities and generics), biologics and biosimilars, advanced therapy medical products (ATMPs), orphan drugs, paediatric medicines and vaccines, as well as over-the-counter products.
Marketing Authorisation Applications
Spectrum has extensive experience in all four routes of filing in the EU. We advise on the optimal route to marketing authorisation and strategies to achieve market access.
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Lifecycle Management
Spectrum can provide support at any stage of the lifecycle, from new candidates entering clinical development through to mature marketed products, to help maximise potential and reduce risk in the face of increasing pressure on the R&D pipeline.
Medical Devices and Diagnostics
We offer guidance on CE marking, regulatory strategies for commercialisation, implementation of management systems and preparation of the technical file. See our full range of medical device services.
Other Industry Sectors
We have consultants specialising in the regulation of cosmetics, functional foods/nutraceuticals, and herbal preparations.
Regulatory Intelligence
The benefits of regulatory intelligence speak for themselves: improved decision-making, better compliance, faster times to market and lower product development costs.
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To find out more about these and other regulatory affairs services from Spectrum, please call us on +44 (0)1403 320280 or contact us by email.
